Document Control Specialist

SUMMARY

This position is responsible for ensuring the Quality System Regulations, distributing new documents and discarding obsolete records. This position will be required to keep records and logs of document retrievals, updates, distributions and removals related to Quality System documentation.   Quality System documentation change control are applied in a compliant manner throughout the organization. This position will update, maintain, and distribute all Quality System documentation to ensure regulatory compliance.  This position will also maintain master and electronic records and files in accordance with written procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Distributes documents for revision to appropriate users and removes obsolete documents within QT9 documentation system or shared server. 
• Maintains “Master” and electronic files of Quality System documentation in QT9 or on shared server.
• Ensures change control compliance, by reviewing completeness, accuracy and proper document approval of documents and quality system records.
• Confer with document originator and approver in a positive collaborative manner to prepare controlled documents which conform to PTS format.
• Helps create and revise quality system documents as required.
• Notifies all affected departments of changes with the quality system and date effective.
• Performs duties as defined in document control policies and procedures.
• Performs scanning and filing of documentation as required.
• Communicates clearly with PTS personnel to ensure document routings and distributions are handled in a timely fashion.
• Supports rework, deviations, and nonconformance processes by assigning numbers, completing MAS tasks, and reviewing documentation for correctness.
• Maintains records regarding the status of all document and change control processes.

QUALIFICATIONS 

• Ability to adapt to change and work flexibly to overcome boundaries  
• Is detail-oriented while maintaining control in an active, sometimes high-traffic environment.
• Able to follow written and verbal instructions
• Able to communicate effectively, both written and verbally, to peers and superiors
• Is fluent in the computer skills required to execute the assigned tasks. 
• Must be able to lift and file documents and binders of varying weight onto rolling shelves.
• Professional, personable demeanor is essential to this role due to the frequent interaction with other staff.

EDUCATION and/or EXPERIENCE 

• High School degree minimum; Associate or Bachelor’s degree from an accredited college or university preferred 
• Three to five (3-5) years of documentation control or related experience in a regulated industry (preferably medical device) is preferred
• Experience with electronic documentation systems is a plus 
• Or, equivalent combination of education and experience

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Employee works in a typical office environment. Must be able to reach and file all types of documentation (small files, large binders, archive boxes, etc.).  

EQUAL OPPORTUNITY EMPLOYER: PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

STATEMENT of OTHER DUTIES DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.